Transcorneal Electrical Stimulation Therapy for Retinal Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00804102 |
Recruitment Status :
Completed
First Posted : December 8, 2008
Last Update Posted : May 4, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Retinitis Pigmentosa Macula Off Primary Open Angle Glaucoma Hereditary Macular Degeneration Treated Retina Detachment Retinal Artery Occlusion Retinal Vein Occlusion Non-Arthritic-Anterior-Ischemic Optic-Neuropathy Hereditary Autosomal Dominant Optic Atrophy Dry Age Related Macular Degeneration Ischemic Macula Edema | Device: Transcorneal Electrical Stimulation Device: DTL-electrode attached without energy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Retinitis pigmentosa |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Macula off
condition after treatment of retinal detachment
|
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Primary open angle Glaucoma |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Hereditary Macular Degeneration |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Treated Retina detachment |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Retinal Artery Occlusion |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Retinal Vein Occlusion |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Hereditary autosomal dominant Optic atrophy |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: dry Age-related Macular Degeneration |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Active Comparator: Ischemic Macula edema |
Device: Transcorneal Electrical Stimulation
Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients. |
Sham Comparator: Non-stimulated |
Device: DTL-electrode attached without energy
DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm. |
- enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema
Exclusion Criteria:
- Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
- Age above 99 years

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804102
Principal Investigator: | Florian Gekeler, MD, Prof | University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Okuvision GmbH |
ClinicalTrials.gov Identifier: | NCT00804102 |
Other Study ID Numbers: |
EST-2008 |
First Posted: | December 8, 2008 Key Record Dates |
Last Update Posted: | May 4, 2012 |
Last Verified: | May 2012 |
Retinitis pigmentosa Macula off Primary open angle Glaucoma Hereditary Macular Degeneration Treated Retina detachment Retinal Artery Occlusion |
Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy Hereditary autosomal dominant Optic atrophy dry Age-related Macular Degeneration Ischemic Macula edema |
Optic Nerve Diseases Optic Neuropathy, Ischemic Optic Atrophy Optic Atrophy, Autosomal Dominant Glaucoma Macular Degeneration Glaucoma, Open-Angle Retinitis Retinal Vein Occlusion Retinitis Pigmentosa Retinal Diseases Retinal Artery Occlusion Retinal Detachment Ischemia Atrophy |
Pathologic Processes Ocular Hypertension Eye Diseases Retinal Degeneration Pathological Conditions, Anatomical Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Eye Diseases, Hereditary Retinal Dystrophies Genetic Diseases, Inborn Arterial Occlusive Diseases Cranial Nerve Diseases |